ACtive Children Enhance LEaRning and AttenTION: A Randomized Controlled Trial (RCT)

Physical Inactivity Clinical Trial

— ACCELERATION  

Official title:

A Randomized Controlled Trial (RCT) of the Impact of School-based Sport Research Program on Children's Physical Activity, Executive Function, and Academic Achievement

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05794360
• Other study ID #: STUDY00003226
• Status: Completed
• Phase: N/A
• Start date: February 2, 2022
• Est. completion date: June 29, 2022

Study information

• Verified date: March 2023
• Source: University of Houston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this clinical trial is to test the effectiveness of sport-based physical education (PE) curriculum on activity behaviors (moderate to vigorous physical activity and sedentary behavior), executive functions, and academic performance in elementary school-aged children, particularly among low-income ethnic minorities. The main questions it aims to answer are: - Whether a school-based sport program can improve child engagement in school-time moderate-to-vigorous physical activity (MVPA) and total daily MVPA, compared to a control group (standard PE class)? - Whether a school-based sport program can improve child executive functions and academic performance, compared to a control group (standard PE class)? Participants randomized to receive the ACtive Children Enhance LEaRning and AttenTION (ACCELERATION) intervention (treatment) received - 45-minute weekly for 10 weeks soccer (ball mastery exercises) curriculum led by trained PE teachers during the school PE lesson time. - Homework required practicing learned ball mastery skills daily for 15-20 minutes at home. A required ball was provided to them. - Virtual parent workshops, which required the attendance of parents of study participants to improve their understanding of all about the program Researchers will compare the control group, who received a regular PE class curriculum, to see if there are any differences in child activity behaviors, executive functions, and academic performance.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 257
• Est. completion date: June 29, 2022
• Est. primary completion date: May 13, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 11 Years

Eligibility

Inclusion Criteria:

1. Any student enrolled in 3rd or 4th-grade classes were eligible to participate in the study.

2. Participation in an extracurricular sports activity wasn't an exclusion criterion for this study.

Exclusion Criteria:

1. Students were excluded if they had serious physical (e.g., asthma, heart diseases), developmental (e.g., autism, attention-deficit hyperactivity), or learning (e.g., dyslexia, dyscalculia, dysgraphia) disorders that prevented them from participating in intervention activities

2. Students who participated in a physical activity intervention within the last 6 months were excluded.

Related Conditions & MeSH terms

• Physical Inactivity

Intervention

Behavioral:
• ACtive Children Enhance LEaRning and AttenTION (ACCELERATION)
A diverse group of key informants (i.e., PE teachers, school athletic department director) and community stakeholders (i.e., professional soccer coaches, Houston Dynamo Academy director) were engaged to help the research team design, modify, and implement the ACCELERATION curriculum to ensure program relevance and appeal. There are several components that described below make our program design both comprehensive and highly adaptable for optimal reach and effectiveness. These include staff development training, parent workshops, on-site and virtual developmental programs, delivery and implementation support from community stakeholders, online resources, family engagement events, equipment donations to improve activity, and on-going support and mentoring services for parents and school-based educators.

Locations

Country	Name	City	State
United States	KIPP Houston Public Schools	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Houston

Country where clinical trial is conducted

United States, 

References & Publications (4)

Basterfield L, Reilly JK, Pearce MS, Parkinson KN, Adamson AJ, Reilly JJ, Vella SA. Longitudinal associations between sports participation, body composition and physical activity from childhood to adolescence. J Sci Med Sport. 2015 Mar;18(2):178-82. doi: 10.1016/j.jsams.2014.03.005. Epub 2014 Mar 15. — View Citation

Diamond A, Lee K. Interventions shown to aid executive function development in children 4 to 12 years old. Science. 2011 Aug 19;333(6045):959-64. doi: 10.1126/science.1204529. — View Citation

Diamond A, Ling DS. Conclusions about interventions, programs, and approaches for improving executive functions that appear justified and those that, despite much hype, do not. Dev Cogn Neurosci. 2016 Apr;18:34-48. doi: 10.1016/j.dcn.2015.11.005. Epub 2015 Dec 7. — View Citation

Eime RM, Young JA, Harvey JT, Charity MJ, Payne WR. A systematic review of the psychological and social benefits of participation in sport for children and adolescents: informing development of a conceptual model of health through sport. Int J Behav Nutr Phys Act. 2013 Aug 15;10:98. doi: 10.1186/1479-5868-10-98. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in the Average Accelerometer-measured MVPA/day at 10 weeks	MVPA behaviors were assessed objectively with accelerometers (GT3X+ Actigraph, Pensacola, FL). Trained research staff instructed the students to wear the accelerometer on the right hip for 8 days, which allowed participant to adapt to wearing the device and to achieve the study goal of 2 valid wear days per child as consistent with school-based evaluations. A valid day were defined as =600 minutes wear time per day. Freedson's age specific cut points for children 6 to 18 years old will be used to determine the intensity of activity.	baseline and post (immediate after 10 weeks of the intervention)
Secondary	Change from Baseline in the Average Accelerometer-measured Sedentary Time/day at 10 weeks	Sedentary behaviors were assessed objectively with accelerometers (GT3X+ Actigraph, Pensacola, FL). Trained research staff instructed the students to wear the accelerometer on the right hip for 8 days, which allowed participant to adapt to wearing the device and to achieve the study goal of 2 valid wear days per child as consistent with school-based evaluations. A valid day were defined as =600 minutes wear time per day. Freedson's age specific cut points for children 6 to 18 years old will be used to determine the intensity of activity.	baseline and post (immediate after 10 weeks of the intervention)
Secondary	Change from Baseline in the Mean Dimensional Change Card Sort Test Score at 10 weeks	NIH Toolbox (appropriate for ages 7+) iPad Cognitive Battery utilized to deliver Dimensional Change Card Sort Test. This task measured the cognitive flexibility of children. Children were shown an on-screen target image and instructed to select one of two images matching the target on either shape or color.	baseline and post (immediate after 10 weeks of the intervention)
Secondary	Change from Baseline in the Mean Flanker Inhibitory Control and Attention Test Score at 10 weeks	NIH Toolbox (appropriate for ages 7+) iPad Cognitive Battery utilized to deliver Flanker Inhibitory Control and Attention Test. For this task, children were shown an arrow flanked by two additional arrows on each side and instructed to choose an on-screen button matching the direction of the middle arrow.	baseline and post (immediate after 10 weeks of the intervention)
Secondary	Change from Baseline in the Mean Picture Sequence Memory Task Score at 10 weeks	NIH Toolbox (appropriate for ages 7+) iPad Cognitive Battery utilized to deliver Picture Sequence Memory Task. Children were shown a narrated sequence of images corresponding to common activities- "How to go to the Park", followed by images depicting children playing on swings, feeding ducks. The same sequence was repeated and the participant was asked to recall the proper sequence.	baseline and post (immediate after 10 weeks of the intervention)
Secondary	Change from Baseline in the Mean the State of Texas Assessments of Academic Readiness (STAAR) Standardized Test Scores at 10 weeks	This test emphasizes students' readiness for success in the grade that follows by assessing the knowledge attained in the current grade level. Students in 3rd and 4th grade are tested on the following subjects, reading, mathematics.	baseline and post (immediate after 10 weeks of the intervention)